Kornimate/medical-research-clean huggingface dataset:
impact of exenatide on sleep duration

Conditions: Type 2 Diabetes

Summary: this study investigates the effect of exenatide, a fda approved medication for the treatment of type 2 diabetes on sleep duration and quality. individuals with type 2 diabetes will be studied before and during treatment with exenatide. enrolled individuals will be asked to come to the university of chicago for 3-4 outpatient visits over the course of 3-4 months.


Eligibility criteria:
inclusion criteria: patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible exclusion criteria: patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as exenatide use is contraindicated or risky in these conditions. patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. patients who have severe copd, severe neuropathy or chronic pain, which could impair sleep, will be excluded. shift workers will be also excluded.
safety and efficacy study of rts,s as02a/as01b vaccine to prevent malaria

Conditions: Malaria

Summary: this is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.


Eligibility criteria:
inclusion criteria: * be in good general health * be able to participate for 4-15 months exclusion criteria: * pregnant or planning pregnancy * history of malaria or exposure to malaria in past 12 months * received an investigational malaria vaccine * past history of allergic reaction to previous immunization * positive blood tests for hiv and specific types of hepatitis

Keywords: malaria
modulation of serca2a of intra-myocytic calcium trafficking in heart failure with preserved ejection fraction

Conditions: Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction

Summary: the goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. the main questions it aims to answer are: * safety and tolerability of the gene therapy; and * whether the gene therapy helps the heart ventricles relax during filling. participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. the first year will have multiple in-person visits followed by 4 years of biannual phone calls.

eligible participants will undergo a one-time antegrade epicardial coronary artery infusion of gene therapy delivered to the 3 major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or bypass grafts unless contraindicated. post-procedure, the subject will be monitored continuously for a minimum of 4 hours and then discharged to home that same day if medically appropriate. participants will be followed for 52 weeks as part of the main trial. on day 2 and week 1, subjects will be contacted by phone for a general safety assessment, and if clinically indicated, an in-person evaluation and assessment will be performed as soon as possible. on weeks 2, 4, 12, 24 and 52, subjects will undergo general safety assessments. additionally, at weeks 24 and 52, subjects will undergo outpatient core resting and exercise transthoracic echocardiography, right heart catheterization with hemodynamic monitoring and gas exchange measurements, 6-minute wall test, cardiac biomarker testing and completion the kansas city cardiomyopathy questionnaire. upon completion of the active observation period, participants will continue to be followed for 4 years with bi-annual, semi-structured telephone or in-person questionnaires that collect information on overall status and other comorbid conditions of interest in gene therapy trials.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * negative for anti-aav1 neutralizing antibodies * nyha class ii or iii * left ventricular ejection fraction ≥ 50% * evidence of resting or exercise-induced left ventricle filling pressure * on oral diuretic therapy * adequate birth control exclusion criteria: * nyha class iv * heart failure requiring hospitalization in the past 3 months * manifested or provocable ischemic heart disease * atrial fibrillation * history of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (lv) aneurysm * history of amyloidosis * untreated left-sided valvular disease * severe copd * bmi \> 50 kg/m\^2 * severe liver, kidney or hematologic dysfunction * cancer within the past 5 years * unstable concurrent conditions
study of efficacy and safety of fingolimod (gilenya) 0.5 mg in chinese patients with relapsing multiple sclerosis (rms) patients

Conditions: Relapsing Multiple Sclerosis (RMS)

Summary: to assess the efficacy and safety of 0.5mg fingolimod (gilenya) in chinese patients with relapsing relapsing multiple sclerosis (rms)

this is a 24-month, open-label, multicenter, interventional, single-arm study to collect efficacy and, safety of oral fingolimod 0.5 mg/day in approximately 100 relapsing multiple sclerosis (rms) subjects in china. the study will consist of three phases: screening (up to 1 month): after signing informed consent, subjects will enter a screening phase to determine eligibility according to inclusion and exclusion criteria. treatment period (24 months): on visit day 1, all eligibility criteria will be confirmed, including a pre-dose ecg and vital signs. the first dose of study drug will be taken in the clinic on day 1 and the subject will be monitored for 6 hours after the first dose administration before discharge. participants will return to site for evaluation at month 1 and then every three months until the end of treatment up to 24 months. follow up (2 months): subjects who completed treatment period or discontinued from treatment will return for the follow-up visit 2 months after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * participant 10 to 17 years old inclusive with weight \> 40kg. * participant 18 to 65 years old inclusive; * participants with relapsing multiple sclerosis * participants never used fingolimod before enrollment * subjects with expanded disability status scale (edss) score of 0 - 6.0 (inclusive) at screening exclusion criteria: * participants with certain cardiovascular conditions and/or findings in the screening ecg. * diagnosis of macular edema during screening visit. * increased risk for opportunistic infections * participants with known active malignancies. * participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout. * participants with severe active infections, active chronic infection. * participants with severe liver impairment. * pregnant confirmed by a positive pregnancy test or nursing (lactating) women. other protocol-specified inclusion or exclusion criteria may apply.

Keywords: relapse multiple sclerosis (rms) fingolimod adult pediatric china
a study of standard drugs for mycobacterium avium complex

Conditions: Mycobacterium Avium Complex

Summary: to assess the early bactericidal activity of azithromycin 250mg by mouth daily over the first 14 days of treatment for mycobacterium avium complex (mac) lung disease.

this research is being done to better understand several important aspects of treatment of mycobacterium avium complex (mac) lung infections using an early bactericidal activity (eba) study design. mac is an environmental bacteria that can cause chronic lung infection. early bactericidal activity is the amount of bacterial killing that occurs during the first few weeks of antibiotic treatment. by collecting information about the eba of azithromycin for mac, the investigators will quantify the efficacy of azithromycin against pulmonary mac.

Eligibility criteria:
inclusion criteria: * age ≥18 years * isolation of m. avium intracellulare complex from a respiratory specimen in the preceding 6 months * fulfill american thoracic society (ats)/infectious diseases society of america (idsa) criteria for mac lung disease * intention by the treating clinician to treat for mac lung disease. * ability to produce a sputum sample of at least 10ml in a 16 hour period * signed informed consent by the subject exclusion criteria: * prior treatment for pulmonary mac within the past 6 months * pregnancy * hiv with a cluster of differentiation 4 (cd4) \<350 * history of solid organ or hematologic transplant * contraindication to azithromycin * has any other condition that, in the opinion of the pi, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
erectile dysfunctions, gonadotoxicity and sexual health assessment in men with lung cancer

Conditions: NSCLC Stage IV; Sex Disorder; Hypogonadism, Male; Erectile Dysfunction

Summary: although many phase iii clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. in light of the long-term efficacy of new-generation anticancer treatments for ansclc (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients. the aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ansclc


Eligibility criteria:
inclusion criteria: * diagnosis of advanced/metastatic nsclc * to be candidate to active treatment * aged ≥ 18 anni (up to 75 years old) * to be sexually active in last 30 days before treatment start * eastern cooperative oncology group (ecog) performance status 0-1 * written informed consent exclusion criteria: * history of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years * any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. examples include, but are not limited to: * cancer-related conditions that may preclude/undermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications): * history of chronic liver disease or hormonal replacement therapy (e.g. adt for prostatic cancer) * participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin) * chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics * psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * major psychological disorder and/or high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study

Keywords: nsclc sexual health male hypogonadism erectile dysfunction
surgery without neoadjuvant chemoradiotherapy compared with neoadjuvant chemoradiotherapy for rectal cancer with negative circumferential resection margin based on mri assessment, a perspective multicenter randomized controlled trial

Conditions: Circumferential Resection Margin; Intraoperative Perforation of Rectum; Local Recurrence of Malignant Tumor of Rectum; Disease-free Survival; Overal Survival

Summary: for now, neoadjuvant chemoradiotherapy is routinely performed for t3n1-2m0 rectal cancer. however, there are lots of complications following neoadjuvant chemoradiotherapy, such as wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an apr, caa or low ar was performed. the main purpose of preoperative radiotherapy is to lower the local recurrence. for the t3n1-2m0 rectal cancer with negative circumferential resection margin based on mri assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.


Eligibility criteria:
inclusion criteria: 1. tumor within 12 cm of the anal verge 2. t3n1-2 as determined by preoperative mri examination 3. negative circumferential resection margin determined by preoperative mri examination 4. absence of distant metastases 5. absence of intestinal obstruction exclusion criteria: 1. with distant metastases 2. with intestinal obstruction 3. pregnancy or lactation 4. with operation contraindication 5. with mental disorder
the effect of combined ephedrine and lidocaine pretreatment on pain and hemodynamic changes due to propofol injection

Conditions: Pain Due to Propofol Injection; Hemodynamic Changes Due to Propofol Injection

Summary: objectives: injection pain and hypotension are two main adverse effects of propofol which distresses patient. the aim of this prospective double blind study was to compare the effect of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and hemodynamic changes due to propofol induction. methods: 165 adult patients, aged 20 to 60 yr, patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(l) ,ephedrine 30microgram/kg (e30), ephedrine 70 microgram/kg(e70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(le) or 2ml saline (s) intravenously. after one minute propofol 2 mg/kg into a dorsal hand vein was injected. face pain scale and verbal rating scale, arterial blood pressure and heart rate were recorded before induction, just before intubation, and one minute after intubation


Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists(asa)physical statusiandii exclusion criteria: * patients with difficulty in communication * history of allergic, neurologic or cardiovascular disease * patients who had received an analgesic medication within 24 hr before surgery

Keywords: propofol ephedrine pain
effect of premature luteinization on the oocyte quality in oocyte donation program.

Conditions: Premature Luteinization

Summary: analyze the possible effect of the progesterone levels of the hcg administration on the oocyte embryo quality. the primary endpoint of this study is the pregnancy rate.


Eligibility criteria:
inclusion criteria: * oocyte donors; age range: 18 - 34; bmi: 18 - 29; long protocol. exclusion criteria: * pco syndrome;
the r4r advance care planning pilot study

Conditions: Advance Care Planning

Summary: affordable housing residents continue to experience multi-faceted insecurity and advance care planning (acp) challenges even after obtaining secure housing, resulting in significant inequities in quality of care during times of cognitive incapacity. to promote proactive planning for affordable housing residents, this proposal is for a pilot study to test a novel trauma-informed care adapted advance care planning intervention with the following aims: to test initial efficacy of the intervention on acp outcomes (aim 1) and determine resident perceptions of intervention acceptability, appropriateness, and feasibility and perceived implementation barriers and facilitators (aim 2). these data will support the development of a larger scale study of acp interventions within a resiliency-based hub model to comprehensively support whole-person care and proactive planning for times of cognitive incapacity.

long-term objectives and goals. vanderbilt university school of nursing (vusn) and urban housing solutions (uhs) - the second largest provider of affordable housing in nashville - are partners with the long-term goal of reducing health disparities among medically-underserved uhs residents in nashville. this partnership is developing resiliency hubs that will provide essential services and support within a communal setting at the housing facility. previous literature and data findings support that similar populations to this community lack information about and access to advance care planning (acp), which specifies their healthcare wishes during cognitive incapacitation or end-of-life, and nationwide research shows significant disparities regarding acp participation among low-income populations. the short-term goal of the proposed work is to pilot test a hybrid type 1, single-arm, pre-post intervention to assess the initial efficacy and implementation outcomes of a trauma-informed care (tic)-adapted acp intervention to improve learning and communication for times of decisional incapacity among uhs residents, within the context of a resiliency hub model. this is a necessary first step for developing a long-term research portfolio dedicated to addressing acp disparities and promoting equitable end-of-life planning among low-income, medically-underserved populations.

Eligibility criteria:
inclusion criteria: * an adult (18+) residing in an affordable housing unit that does not have a completed advance directive exclusion criteria: * inability to provide informed consent or participate in the intervention due to cognitive, auditory, visual impairment or non-english language barrier

Keywords: advance care planning affordable housing housing insecurity social determinants of health trauma-informed care qualitative research implementation science
combined steroid and cyclosporin as first-line treatment in adults with primary immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: randomized, open-label, multicenter study to compare the efficacy and safety of cyclosporin plus standard steroid compared to standard steroid monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (itp).

the investigators are undertaking a parallel group, multicenter, randomized controlled trial of 253 adults with itp in china. patients were randomized to cyclosporin plus standard steroid compared to standard steroid monotherapy group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. newly-diagnosed, treatment-naive primary itp; 2. platelet counts \<30×10\^9/l; 3. platelet counts \< 50×10\^9/l and significant bleeding symptoms (who bleeding scale 2 or above); 4. willing and able to sign written informed consent. exclusion criteria: 1. pregnant or lactating women; 2. secondary itp (have a known diagnosis of connective tissue diseases, malignancy, active infection, hiv infections or hepatitis b virus or hepatitis c virus infections); 3. received first-line and second-line itp specific treatments (e.g., steroids, intravenous immunoglobulin, tpo-ras, rhtpo, rituximab, etc); 4. received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc); 5. severe medical condition (lung, heart, hepatic or renal disorder); 6. patients who are deemed unsuitable for the study by the investigator.
study of ono-4538 in non-squamous non-small cell lung cancer (tasuki-52)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of study is to compare the efficacy and safety of ono-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ono-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage iiib/iv or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.


Eligibility criteria:
inclusion criteria: * subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer * subjects who received a diagnosis of stage iiib/iv or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the uicc-tnm classification (7th edition) with no prior systemic anticancer therapy * subjects with at least one measurable lesion by radiographic tumor assessments per recist 1.1 criteria * subjects who are able to provide tumor tissue specimens. * eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1 exclusion criteria: * subjects with known egfr mutations, including deletions in exon 19 and exon 21 (l858r) substitution mutations. * subjects with known alk translocations. * complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds * subjects with autoimmune disease or known chronic or recurrent autoimmune disease. * subjects with multiple cancer.
neural stem cells therapy for cerebral palsy

Conditions: Cerebral Palsy

Summary: to evaluate the safety and efficacy of neural stem cells (nscs) therapy for cerebral palsy.

cerebral palsy is the most severe lifelong disability disease in childhood. in china, an epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about 6.50-9.75 million) of children suffered from cerebral palsy. the costs of medical expenses, living allowance and nursing care can go up to rmb 20000-50000 yuan per year for each child with cerebral palsy and thus china will expend rmb 120-300 billion yuan per year for children with cerebral palsy. with full liberalization of two-child policy, there is an increasing number of second babies born to women who are 35 years or older. thus, the incidence of cerebral palsy tends to increase. there is currently no cure for cerebral palsy, resulting in a heavy burden for families and on society. recent clinical trials performed in countries outside china have demonstrated that stem cell therapy is likely the most effective method to treat cerebral palsy. fifteen trials regarding stem cell therapy for cerebral palsy have been registered with clinicaltrials.gov. in china, there have been no standardized registered trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical application. in october 2016, the national health and family planning commission and the food and drug administration of china jointly announced the premier stem cell clinical research institutions, making performing standardized trials regarding stem cell therapy for cerebral palsy in china possible.

Eligibility criteria:
inclusion criteria: * neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants); * clinical manifestation of spastic tetraplegia; * with moderate to severe cerebral palsy, the gross motor function; classification system (gmfcs) levels iv-v; * age 1-5 years, of either sex; * provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study; exclusion criteria: * systemic diseases that possibly influence treatment or patient's compliance; * potentially life-threatening diseases involving various organ systems; * brain deformity; * abnormal behaviors or mood disorder; * allergies from blood products; * suffering from infectious disease; * subjected to craniocerebral operations prior to screening.